DURECT Announces Positive Phase 1 Data for DUR-928

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DURECT Corporation
DRRX
today announced the successful completion of a Phase 1 clinical trial with an injectable formulation of DUR-928 intended for acute use indications. DUR-928 is an endogenous, small-molecule, new chemical entity (NCE), which may have broad applicability in metabolic diseases such as nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), and in acute organ injuries such as acute kidney injury (AKI). "It's nice to cap off a solid year of progress in 2015 by reporting the successful conclusion of this Phase 1 study of DUR-928 for acute use indications," said James E. Brown, President and CEO of DURECT. "During 2015 more than 75 healthy volunteers received DUR-928 given either orally or through injection at varying doses in excess of endogenous levels, with no treatment related adverse events reported. Building on our learnings from 8 animal models that were previously reported, we now look forward to beginning patient studies in our chronic metabolic and acute use programs in 2016." Phase 1 Injectable Study The Phase 1 trial of DUR-928 began as a single-site, randomized, double-blinded, placebo-controlled, single-ascending-dose study that evaluated the safety, tolerability and pharmacokinetics of 4 doses DUR-928 when administered through an intramuscular injection. The 24-subject study evaluated DUR-928 in four cohorts of healthy volunteers receiving DUR-928 (n = 16 on drug, 8 on placebo) at escalating doses that resulted in peak plasma concentrations over 100 fold higher than endogenous levels. DUR-928 was well-tolerated at all dose levels, with no treatment-related adverse events reported and plasma levels were dose proportional. Before the highest dose was added to the single-ascending-dose study, we proceeded to a multi-dose cohort including 10 healthy volunteers, in which study participants received DUR-928 for 5 consecutive days (n = 8 on drug, 2 on placebo) with what at the time was our highest dose in the prior study. No treatment related adverse events were reported, no subjects withdrew from the study, no accumulation in plasma concentrations were observed with repeat dosing, and the pain scores and injection site reactions were minimal.
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